RESEARCH TRIANGLE PARK, N.C., July 21, 2026
Merakris Therapeutics announced that it has received a Direct-to-Phase II Small Business Innovation Research (SBIR) award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH), to support the clinical development of MTX-001 for the treatment of diabetic foot ulcers (DFUs). The two-year award is expected to provide approximately $2.2 million in non-dilutive funding, enabling the company to expand its clinical-stage regenerative biologics pipeline into a second major chronic wound indication while complementing its ongoing FDA Fast Track-designated venous leg ulcer (VLU) program. The funding also represents independent scientific validation of the company’s therapeutic platform, manufacturing capabilities, and long-term clinical development strategy.
MTX-001 Targets Chronic Wounds with a Dual-Action Regenerative Approach
MTX-001 is Merakris Therapeutics’ lead investigational biologic, designed to address the underlying biological causes of chronic wound persistence rather than simply providing wound coverage. The therapy features a dual-action mechanism that simultaneously modulates excessive inflammation and protease activity, helping restore an environment conducive to healing, while also activating endogenous epithelial cells responsible for tissue regeneration and re-epithelialization. By targeting both inflammatory damage and impaired tissue repair, MTX-001 aims to offer a differentiated treatment option for patients suffering from diabetic foot ulcers and venous leg ulcers, two of the largest chronic wound indications with significant unmet medical need.
NIH-Funded Program Supports Randomized Clinical Development
The NIH-supported study will evaluate MTX-001 in patients with diabetic foot ulcers using a randomized, placebo-controlled clinical trial design, with all participants continuing to receive current standard wound care, including debridement, off-loading, and comprehensive wound management. Merakris Therapeutics also plans to engage with the U.S. Food and Drug Administration (FDA) to discuss its broader clinical development strategy for MTX-001 in diabetic foot ulcers. In parallel, the company recently initiated Good Manufacturing Practice (GMP) pilot-scale production of clinical material and continues advancing its Chemistry, Manufacturing and Controls (CMC) platform to support future late-stage clinical studies and potential commercialization.
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Pipeline Expansion Strengthens Merakris’ Regenerative Medicine Strategy
The new diabetic foot ulcer program complements Merakris Therapeutics’ ongoing Phase II clinical trial evaluating MTX-001 for venous leg ulcers (ClinicalTrials.gov Identifier: NCT04647240), which recently received FDA Fast Track Designation. Together, these programs establish MTX-001 as a clinical-stage regenerative biologic platform targeting two of the most prevalent chronic wound conditions worldwide. Company leadership believes that combining non-dilutive NIH funding, expanding regulatory progress, scalable manufacturing capabilities, and a differentiated biological mechanism positions Merakris Therapeutics to accelerate development of innovative regenerative therapies while addressing a substantial global market for chronic wound treatment.
Source: Merakris Therapeutics, press release
